BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1398170 · Received June 1, 2009

    Report

    Report Number
    2024168-2009-00953
    Event Type
    Death
    Date Received
    June 1, 2009
    Date of Event
    May 6, 2009
    Report Date
    May 7, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT IN 2008, THE 3.0 X 18 MM PROMUS STENT WAS IMPLANTED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD), WHICH HAD SEVERE CALCIFICATION AND WAS MODERATELY TORTUOUS. THE PATIENT WAS DISCHARGED THREE DAYS LATER; HOWEVER, DIED BEFORE THEIR SIX MONTH FOLLOW UP IN 2009. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR AS BSC DISTRIBUTES PROMUS IN THE US AS ITS BRAND LABEL OF ABBOTT VASCULAR'S DRUG ELUTING STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8071541

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death